QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

FDA 510(k)

FDA Class 2 ·Immunology

Advanced Medical Imaging Software Suite (KSWVWR)

FDA 510(k)

FDA Class 2 ·Radiology

STERISPINE LC CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

Sim&Size

FDA 510(k)

FDA Class 2 ·Radiology

Epione

FDA 510(k)

FDA Class 2 ·Radiology

PASS LP SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

UNIRING - ANNULOPLASTY RING WITH SIZERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNiD Patient Specific 3D printed cage

FDA 510(k)

FDA Class 2 ·Orthopedic

ABX PENTRA TPU CAL, MODEL A11A01898

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Axialis Ophthalmic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

MICROALBUMINURIA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)

FDA 510(k)

FDA Class 2 ·Orthopedic

VX120 Ophthalmic Diagnostic Device

FDA 510(k)

FDA Class 2 ·Ophthalmic

QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

FDA 510(k)

FDA Class 2 ·Immunology

DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN

FDA 510(k)

FDA Class 2 ·Cardiovascular

MRCAT Pelvis

FDA 510(k)

FDA Class 2 ·Radiology

Idys ALIF TiVac

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic